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Immune Response to SARS-CoV-2 (COVID-19) Vaccines in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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ClinicalTrials.gov Identifier: NCT04852822
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : May 20, 2021
Sponsor:
Collaborator:
CLL Global Research Foundation
Information provided by (Responsible Party):
University of Washington

Brief Summary:
This study evaluates the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer that begin in cells of the immune system. CLL/SLL and the medications used to treat these conditions may change the way vaccines work in a patient's body. The purpose of this study is to find out if patients with CLL/SLL make antibodies, or have an immune response, to the SARS-CoV-2 vaccines. Information gained from this study may help researchers better understand how effective the vaccines work in preventing COVID-19 (coronavirus disease 2019) in patients with CLL and SLL.

Condition or disease Intervention/treatment
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Procedure: Biospecimen Collection Other: Electronic Health Record Review

Detailed Description:

OUTLINE:

For patients who have not been vaccinated at the time of enrollment, they will undergo collection of blood samples prior to the first vaccine dose, just before the second vaccine dose, and then at 1, 6, and 12 months after the second vaccine dose. Patients' medical records are also reviewed.

For patients enrolled after vaccination, they will undergo collection of blood samples at 1, 6, and 12 months after completing the vaccination series.

After completion of study, patients are followed up every 6 months for 2 years.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Evaluation of SARS-CoV-2 Vaccines in Patients With CLL/SLL
Actual Study Start Date : March 18, 2021
Estimated Primary Completion Date : August 8, 2022
Estimated Study Completion Date : August 8, 2022


Group/Cohort Intervention/treatment
Observational (biospecimen collection, medical record review)
Patients undergo collection of blood samples on the day of the second vaccine dose, and then at 1, 6, and 12 months after the second vaccine dose. Patients' medical records are also reviewed.
Procedure: Biospecimen Collection
Undergo collection of blood samples

Other: Electronic Health Record Review
Medical records are reviewed




Primary Outcome Measures :
  1. Response rate to the SARS-CoV-2 vaccine among patients with chronic lymphocytic leukemia/small lymphocytic lymphoma [ Time Frame: Up to 2 years ]

Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who receive a SARS-CoV-2 vaccine
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • A diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Exclusion Criteria:

  • Any known history of prior SARS-CoV-2/COVID19 infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04852822


Contacts
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Contact: Amy Sperling 206-606-1386 sperla2@seattlecca.org

Locations
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United States, California
City of Hope Not yet recruiting
Duarte, California, United States, 91010
Contact: Osbaldo Rodriguez    626-218-9108    osrodriguez@coh.org   
Principal Investigator: Tanya Siddiqui, MD         
Principal Investigator: Alexey Danilov, MD, PhD         
University of California Irvine Not yet recruiting
Orange, California, United States, 92868
Contact: Billy Sanchez    714-456-7242    billyjs@hs.uci.edu   
Principal Investigator: Susan O'Brien, MD         
University of California San Diego Not yet recruiting
San Diego, California, United States, 92093
Contact: Monica Spydell    858-353-5975    mmspydell@health.ucsd.edu   
Principal Investigator: Michael Choi, MD         
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Chiquita McCoy    202-687-8149    cm1857@georgetown.edu   
Principal Investigator: Catherine Lai, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Ramon Arza    305-243-6777    raa241@miami.eduraa241@miami.edu   
Principal Investigator: Georgios Pongas, MD         
United States, Massachusetts
Dana-Farber Cancer Center Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Peter Baker    617-632-5497    PeterO_Baker@DFCI.HARVARD.EDU   
Principal Investigator: Matt Davids, MD         
Principal Investigator: Christine Ryan, MD         
United States, Ohio
Cleveland Clinic Taussig Cancer Center Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Natasha Goldsby       GOLDSBN@ccf.org   
Principal Investigator: Allison Winter, MD         
Principal Investigator: Brian Hill, MD, PhD         
Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Arianna Crouse    614-366-2563    Arianna.Crouse@osumc.edu   
Principal Investigator: Kerry Rogers, MD         
Principal Investigator: Jennifer Woyach, MD         
United States, Oregon
Oregon Health & Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Maria Jimenez Valencia    503-418-1660    jimenema@ohsu.edu   
Principal Investigator: Stephen Spurgeon, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jon Hernandez    713-745-0259    JAHernandez5@mdanderson.org   
Principal Investigator: Philip A. Thompson, MD         
United States, Utah
University of Utah / Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Natalie Rojas    801-213-6231    Natalie.Rojas@hci.utah.edu   
Principal Investigator: Deborah Stephens, DO         
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Amy Sperling    206-606-1386    sperla2@seattlecca.org   
Principal Investigator: Chaitra S. Ujjani, MD         
Sponsors and Collaborators
University of Washington
CLL Global Research Foundation
Investigators
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Principal Investigator: Chaitra S. Ujjani, MD Fred Hutch/University of Washington Cancer Consortium
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT04852822    
Other Study ID Numbers: RG1121418
NCI-2021-02178 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10646 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell